Characterization of Rhythmicity Profiles of Bradykinin-mediated Angioedema Attacks Using a Tracking Smartphone Application. (ANGIOAPP)

Rhythmicity Profiles of Bradykinin-mediated Angioedema.

Bradykinin-mediated angioedema is a rare and disabling disease, characterized by the occurrence of attacks marked by localized swelling of skin, but also of the airways, which can be life-threatening. The unpredictable nature of attacks is a key feature of angioedema, placing patients under constant threat. It seems that there are different patterns of yearly distribution for these attacks, but this is poorly described in the literature. The objectives of the study are to establish different rhythmicity profiles of patients according to the frequency of the attacks; and to identify factors potentially triggering the attacks. For this purpose, patients with bradykinin-mediated angioedema will be monitored daily using a smartphone application. Each day, the application will ask the patient if he or she is having an attack and, if so, the characteristics of the attack and the events preceding it

Study Overview

• Status: Withdrawn
• Conditions: Bradykinin-mediated Angioedema
• Intervention / Treatment: Other: Questionnaire on a smartphone application

• Study Type: Observational

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with bradykinin-mediated angioedema, aged 18 years or older, followed in the internal medicine department of the Lille University Hospital.

Description

Inclusion Criteria:

• Diagnosis of bradykinin-mediated angioedema
• Age > 18
• Having a smartphone
• Non opposition to answer the questionnaire

Exclusion Criteria:

• Patients with other type (histaminergic) angioedema
• Patient unable or unwilling to use a smartphone application
• Opposition to the research
• Minor or protected adult
• Person deprived of liberty

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with bradykinin-mediated angioedema; Patients with bradykinin-mediated angioedema, aged 18 years or older, followed in the internal medicine department of the Lille University Hospital	Other: Questionnaire on a smartphone application; Each day, the smartphone application will ask the patient if he or she is having an angioedema attack. It not, the questionnaire will stop. If the patient is having an attack, a series of 5 short questions is asked about the attack characteristics and the events that preceded it.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Average number of bradykinin-mediated angioedema attacks	Follow up during 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The average number of attack by time of year (months, seasons)		Follow up during 1 year
The average duration of an attack episode		Follow up during 1 year
The average duration between two attacks		Follow up during 1 year
Number of stable clusters of patients that may be drawn out of the data based on attack rhythmicity measures and characteristics of these clusters in each and every cluster.	Number of stable clusters of patients that may be drawn out of the data based on attack rhythmicity measures (based on the number of attacks, the average duration of an attack episode, and the average duration between two attacks) and characteristics of these clusters (mean and standard deviation of rhythmicity measures) in each and every cluster. Stability and information metrics grounding the choice of the number of clusters and their analysis: Bootstrapped Jaccard stability index of clusters, and its 95% confidence interval; Silhouette value of the clustering; Share of intra-cluster variance	After a year of follow up
Individual number of crisis	Descriptif between patient's characteristics ( age, sex, disease onset and treatments) and Individual attack rhythmicity measures(secondary outcome measures n°2) Coefficients (with 95% intervals and Wald test p-values) and pseudo-R² of a Poisson regression modeling the individual number of crisis based on age, sex, disease onset and treatments.	After a year of follow up
Type of attack triggering events	In the application ,question is : "In the 48 hours preceding the onset of the crisis, did you identify one or more of the following events? (several answers possible) Multiple choice can be one or more between Physical activity; Local trauma (blow, injury ...); Dental or surgical procedure; Psychological stress or emotion; Infection; Periods / menstruation; Medication; Other (specify).	After a year of follow up

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Sébastien SANGES, MD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2022
• Primary Completion (Estimated): August 1, 2023
• Study Completion (Estimated): August 1, 2023

Study Registration Dates

• First Submitted: February 24, 2022
• First Submitted That Met QC Criteria: March 21, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Actual): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Smartphone; Bradykinin; Angioedema; Application; Attack; Hereditary angioedema
• Additional Relevant MeSH Terms: Hereditary Complement Deficiency Diseases; Primary Immunodeficiency Diseases; Vascular Diseases; Cardiovascular Diseases; Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immunologic Deficiency Syndromes; Skin Diseases; Urticaria; Skin Diseases, Vascular; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Angioedema; Angioedemas, Hereditary
• Other Study ID Numbers: 2021_05; 2021-A02400-41 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No